Latest news with #Rexulti
Mint
4 days ago
- Health
- Mint
Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
Otsuka Pharmaceutical Co.'s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades. The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established. Panelists struggled to make sense of Otsuka and Lundbeck's supporting evidence, which included one successful study and one in which combining Rexulti with sertraline showed no effect on the symptoms of PTSD. 'I'm looking at these studies and I'm just not convinced the combination offers me as a clinician a new tool in the toolbox,' said Murray Raskind, a psychiatrist at the University of Washington. The Psychopharmacologic Drugs Advisory Committee's recommendations aren't binding, but are often followed by the agency. FDA Commissioner Marty Makary has repeatedly mentioned PTSD as a condition for which new medicines are needed, specifically for veterans. 'We owe it to that community to review some of the potential therapeutics and get a decision out without any delays,' he said in June. The drugmakers have been seeking to broaden the approved usage of brexpiprazole, which is currently cleared for treating schizophrenia in adults and adolescents, as well as an an adjunctive therapy to antidepressants in adults with major depressive disorder. In 2023, the FDA also approved brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease. The drug was discovered by Otsuka, and the Japanese drugmaker is co-developing it with Lundbeck. Post-traumatic stress disorder or PTSD affects about 5% of the population in the US in a given year, according to the companies. It can develop after life-threatening or traumatic events and only two medications — sertraline and paroxetine — are approved in the US to treat it. The drugs' response rates rarely exceed 60%, and fewer than 30% of patients experience full remission, according to the FDA. This article was generated from an automated news agency feed without modifications to text.
Bloomberg
4 days ago
- Health
- Bloomberg
Otsuka, Lundbeck's PTSD Drug Fails to Win US FDA Panel Support
Otsuka Pharmaceutical Co. 's medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades. The panel of external advisers to the Food and Drug Administration voted 10-to-1 on Friday that the efficacy of the companies' brexpiprazole tablets marketed under the brand name Rexulti — in combination with sertraline — hadn't been established.
Yahoo
09-04-2025
- Health
- Yahoo
AAN 2025: Axsome Therapeutics' treatment for Alzheimer's agitation shows promise
On 7 April 2025 at the American Academy of Neurology (AAN) 2025 annual meeting held in San Diego, California, Axsome Therapeutics presented efficacy and safety data from the Phase III ACCORD-2 (NCT04797715) study evaluating AXS-05 (bupropion + dextromethorphan) for the treatment of agitation associated with Alzheimer's disease. The US Food and Drug Administration (FDA) granted AXS-05 fast track designation then breakthrough therapy designation for Alzheimer's agitation in May 2017 and June 2020. During the presentation, Axsome Therapeutics announced plans to file for FDA approval in the spring/summer of 2025. If approved, AXS-05 would become the second drug available for the treatment of Alzheimer's agitation in the US following years of off-label antipsychotic use, intensifying competition in the space. The primary endpoint in ACCORD-2 was met, as AXS-05 treatment significantly delayed the time to relapse of Alzheimer's agitation compared with placebo, with the risk of relapse with AXS-05 3.6 times less than with placebo. 8.4% of patients in the AXS-05 treatment arm experienced agitation relapse compared with 28.6% of patients in the placebo arm, showing that the drug was also significantly effective in prevention. AXS-05 treatment also significantly reduced the worsening of agitation compared with placebo. A major unmet need in the market is for treatments for the many secondary symptoms that can negatively impact patients' and caregivers' quality of life. Key opinion leaders (KOLs) previously interviewed by GlobalData highlighted agitation as a particularly distressing symptom with a lack of good treatment options. At the AD/PD 2025 International Conference on Alzheimer's and Parkinson's Diseases held in Vienna, Austria, in early April 2025, during a symposium sponsored by Bristol Myers Squibb that focused on the neuropsychiatric dimensions of Alzheimer's, the unmet need for the management of agitation was further highlighted. Up to 75% of patients can present with this issue and it is associated with a more rapid decline in cognition and function, resulting in increased risk of earlier patient institutionalisation and increased risk of mortality. Agitated patients are often prescribed antipsychotic medications and sedatives off-label to alleviate behavioural issues. The FDA states that this practice can be dangerous for the elderly. In 2023, Otsuka Pharmaceuticals' Rexulti (brexpiprazole) became the first FDA-approved treatment for agitation associated with Alzheimer's in the US, but KOLs felt that Rexulti's efficacy was only comparable to other atypical antipsychotics and thus did not provide a significant breakthrough for Alzheimer's agitation treatment. AXS-05's positive efficacy is therefore particularly significant, as it would provide a novel, non-antipsychotic treatment option if approved. AXS-05's novel mechanism of action was highlighted as promising for Alzheimer's agitation during the BMS AD/PD 2025 symposium, particularly when compared to Rexulti. Unfavourable opinion about the use of atypical antipsychotics for Alzheimer's agitation is chiefly due to their side-effect profiles. In ACCORD-2, AXS-05 was well tolerated, with no serious treatment-emergent adverse events (TEAEs) and no-one discontinuing the drug due to TEAEs. AXS-05 was also not associated with sedation or cognitive decline, and the overall safety profile is well established following its approval under the brand name Auvelity for major depressive disorder (MDD) in the US in 2022. Physician experience with Auvelity in MDD and its safety profile should give it a further competitive edge in the AD market. Other products in late-stage development for AD agitation are Suven Life Sciences's 5-hydroxytryptamine receptor 6 antagonist masupirdine and BioXcel Therapeutics' alpha 2 adrenergic receptor agonist Igalmi (dexmedetomidine). BMS's M1–M4 muscarinic agonist Cobenfy (trospium chloride + xanomeline tartrate), which is currently marketed for schizophrenia, is in the late-stage pipeline for psychosis associated with Alzheimer's, for which there are no approved drugs. While these products will begin to help meet the present need, both Axsome Therapeutics and BioXcel Therapeutics are currently focusing on development in the US only, so opportunity will remain outside the US. "AAN 2025: Axsome Therapeutics' treatment for Alzheimer's agitation shows promise" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
06-02-2025
- Business
- Yahoo
H. Lundbeck AS (HLUBF) (FY 2024) Earnings Call Highlights: Record Revenue and Strategic Growth ...
Revenue: DKK22 billion, growing 14% at constant exchange rates. Adjusted Gross Margin: 88.4%, increasing 0.1 percentage points. Sales and Distribution Costs: Increased 10% to DKK8.1 billion. Administrative Expenses: Increased 11% to DKK1.4 billion. R&D Costs: Increased by 30% to DKK4.5 billion. Adjusted EBITDA: Increased by 20%, with a margin of 28.8%. EBIT: Increased by 15% to DKK3.3 billion. Net Financials: Income of DKK450 million, an increase of 322%. Effective Tax Rate: Dropped to 15.5% from 23.5%. Net Profit: Increased by 37% to DKK3.1 billion. Cash Flow from Operating Activities: Inflow of DKK3.3 billion. Net Debt: Increased to DKK12.2 billion. Net Debt-to-EBITDA Ratio: 2.4%. Vyepti Revenue: DKK2.909 billion, 72% growth year-on-year. Rexulti Revenue: Global revenue increased 16% in 2024. Brintellix Revenue: 14% growth to DKK4.847 billion. Abilify Franchise Revenue: Grew 10% to DKK3.5 billion. Warning! GuruFocus has detected 2 Warning Signs with HLUBF. Release Date: February 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. H. Lundbeck AS (HLUBF) reported a record revenue of DKK22 billion for 2024, marking a 14% growth at constant exchange rates. Strategic brands, including Rexulti and Vyepti, showed strong performance with a 21% growth, contributing significantly to the company's revenue. The company has a robust pipeline with late-stage developments, including the progression of bexicaserin and anti-PACAP programs. Vyepti's global net revenue grew by 72% year-on-year, with strong adoption in both the US and international markets. The company maintains a healthy financial dynamic with an adjusted EBITDA margin greater than 30%, despite increased R&D investments. H. Lundbeck AS (HLUBF) faced increased administrative expenses due to high legal provisions for ongoing litigations. R&D costs rose by 30%, reaching DKK4.5 billion, driven by investments in new programs and an impairment loss recognized in Q3 2024. The company anticipates generic competition for Brintellix in Canada and Abilify in Europe, which could impact future revenue. There was some destocking observed for both Rexulti and Vyepti, affecting inventory levels and potentially impacting short-term sales figures. The effective tax rate dropped significantly to 15.5%, which may not be sustainable in the long term, affecting future profitability. Q: Can you explain the recent dip in Vyepti's performance and any seasonal effects that might have influenced it? Also, how do you see the competitive dynamics in the major depressive disorder space affecting Rexulti and Brintellix in FY25? A: Charl Van Zyl, CEO, noted that fluctuations are normal, and the underlying trend for Vyepti remains solid, supporting confidence for 2025. Thomas Gibbs, EVP, added that Vyepti is the fastest-growing anti-CGRP, with December's performance being the highest all year. Regarding Rexulti, it has shown strong growth in MDD, and the competitive landscape is evolving with CAPLYTA's expected MDD indication in late 2025. The acquisition of intracellular by J&J is not expected to significantly change the competitive dynamics. Q: What is the status of recruitment for Amlenetug, and how do you plan to address potential challenges in patient recruitment? A: Johan Luthman, EVP of R&D, stated that the Phase II program for Amlenetug had strong recruitment, and they expect similar enthusiasm for Phase III. The trial is expanding to more sites and geographies, and there is significant interest from clinicians and patients, which should aid recruitment efforts. Q: Have you received any updates from the FDA regarding the AdCom for brexpiprazole in PTSD? A: Johan Luthman mentioned that the FDA has communicated the need for an AdCom, which is not routine but understandable given the lack of new treatments for PTSD in over two decades. The date for the AdCom and a potential new PDUFA date are yet to be set. Q: Could you provide more details on the destocking of Vyepti and Rexulti and its impact on Q4 results? A: Thomas Gibbs explained that inventory levels for both products were at the lower end of the normal range by the end of Q4, but they have since rebounded to normal levels in January. This destocking was a temporary fluctuation and not indicative of underlying demand. Q: What are your expectations for the tax rate in 2025, given the significant drop in 2024? A: Joerg Hornstein, CFO, stated that the tax rate for 2025 is expected to be in the range of 21% to 24%, aligning with historical levels. The drop in 2024 was due to a reversal of an uncertain tax position. Q: How do you plan to commercialize Vyepti in Asia, and will it involve a partner? A: Michala Fischer-Hansen, EVP, mentioned that they are exploring options for Vyepti's commercialization in Asia, which may include partnerships, depending on regulatory timelines and market dynamics. Q: Can you elaborate on the competitive landscape for MSA and the potential impact of new developments? A: Johan Luthman noted that while the MSA space is not crowded, recent developments, such as an oral agent showing promise, are being monitored. Lundbeck welcomes more activity in the space, as it can increase awareness and interest in MSA treatments. Q: What are the expected conversion rates for Abilify Maintena to the two-month formulation, and how do you see this impacting growth? A: Michala Fischer-Hansen stated that they expect a conversion rate of 20% to 25% from the one-month to the two-month formulation, with additional conversions from oral medications. This is expected to drive growth, particularly in the US and Europe. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
